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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207931
Company: ABBVIE

Medication Guide

Products on NDA 207931

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNIVIE	OMBITASVIR; PARITAPREVIR; RITONAVIR	12.5MG;75MG;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207931

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207931Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207931s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207931Orig1s013ltr.pdf
07/23/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207931s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207931Orig1s012ltr.pdf
11/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s011lbl.pdf
03/22/2017	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s007,207931Orig1s009ltr.pdf
02/14/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s008ltr.pdf
03/22/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s007,207931Orig1s009ltr.pdf
02/24/2017	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s006Replacementltr.pdf
06/22/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s004ltr.pdf
01/28/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s002ltr.pdf
10/22/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s001ltr.pdf

Labels for NDA 207931

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207931s013lbl.pdf
07/23/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207931s012lbl.pdf
11/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s011lbl.pdf
03/22/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf
03/22/2017	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf
03/22/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf
02/24/2017	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s006lbl.pdf
02/14/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s008lbl.pdf
06/22/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931Orig1s004lbl.pdf
01/28/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931s002lbl.pdf
10/22/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf
07/24/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931Orig1s000lbl.pdf

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